Vaxcyte · 11 hours ago
Executive Director, Clinical Regulatory
United States
Full-time
Remote
Director/Executive
$299K/yr - $349K/yr
15+ years expVaxcyte is a clinical-stage vaccine innovation company focused on developing high-fidelity vaccines to combat bacterial diseases. The Executive Director of Clinical Regulatory will be responsible for creating and implementing global regulatory strategies for clinical studies and commercialization of vaccines, while ensuring compliance with regulatory requirements and leading cross-functional teams.
BiopharmaBiotechnologyHealth Care
Responsibilities
Develop and execute globally viable clinical regulatory strategies
Develop, author and review regulatory CMC documentation for submission including application documents, correspondence and responses to queries. This includes requests for scientific advice in EU, Switzerland, UK and Canada, etc
Provide regulatory guidance for L2, L3 and L4 cross functional development teams
Ensure adherence to current regulatory requirements and alignment with appropriate regulatory guidance (including ICH) and industry best practices
Serve as a primary point of contact with regulatory authorities, i.e., FDA, EMA, MHRA, PMDA, Health Canada, etc., as appropriate
Contribute to the development of product label claims and justifications for clinical outcomes
Lead interactions and negotiations w/global regulatory authorities for reconciliation of specific clinical and pre-clinical issues to expedite regulatory application submissions and approvals
Support regulatory requirements for safety/pharmacovigilance notifications to regulatory authorities
Provide guidance on contemporary regulatory intelligence, statutory legislation and changes in regulatory authority requirements and expectations
Manage cross-functional teams to demonstrate and ensure regulatory compliance
Optionally, people development and management may be expected
Qualification
Required
BA or BS in a relevant scientific or technical discipline, i.e., clinical pharmacology, immunology, biology, medicine, bioanalytics or related life sciences, is required with 15+ years industry experience that demonstrates technical and regulatory expertise and competence
10+ years of extensive and relevant regulatory experience with a proven record of achievement in developing and prosecuting regulatory submissions and application approvals within the pharmaceutical or biotechnology industry with a particular emphasis on vaccines and clinical content
A thorough understanding of clinical development, statistics with particular experience with vaccine development and commercialization
Direct experience engaging multiple health authorities, i.e., FDA, EMA, MHRA, Health Canada, etc., and preparation of regulatory applications for global health authorities
Demonstrated ability to lead and manage cross-functional teams, developing and establishing regulatory strategies and preparing regulatory applications including review and submission of clinical and pre-clinical documentation to regulatory authorities
Direct experience developing clinical regulatory strategies and submissions to effectively manage labelling for global markets and post-approval changes and optimizations for commercial vaccines
Demonstrated record identifying clinical and regulatory risks and developing strategies and/or contingencies for mitigation
Experience translating and integrating contemporary regulatory intelligence into appropriate internal policies and practice
Articulate oral and written communication skills
Active listening
Strategic and tactical critical thinking
Constructive operational productivity
Adaptability
Flexible and optimistic demeanor
Preferred
Graduate education and/or professional certifications or training in regulatory and/or quality are a bonus
Benefits
Comprehensive benefits
Equity component
Company
Vaxcyte
Vaxcyte focuses on developing vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$3.85BKey Investors
CARB-XTPG GrowthAbingworth
2024-09-04Post Ipo Equity· $1.5B
2024-01-30Post Ipo Equity· $862.5M
2023-04-19Post Ipo Equity· $500M
Leadership Team
Andrew Guggenhime
President & Chief Financial Officer
Jeff Fairman
Founder and Vice President, Research
Recent News
2026-01-23
Company data provided by crunchbase